Information and services website for entrepreneurs

Certificate of Pharmaceutical Product

Do you produce medicines in Poland as an entrepreneur and want to sell them abroad? You should first obtain a Certificate of Pharmaceutical Product (CPP). Read below to find out more about the procedure.

How to proceed

This procedure can be completed:

  • at an office
  • by post
  • electronically

What you should know and who can use this service

The Certificate of Pharmaceutical Product is an international document issued for a medicinal product for the purpose of its registration in a given country. The certificate confirms that the manufacturer of the medicinal product is authorised to manufacture the product which is to be placed on the international market.

The Certificate is issued on the basis of World Health Organization (WHO) guidelines by competent authorities in the member states of this organisation. In Poland, the certificate is issued by the Chief Pharmaceutical Inspectorate (GIF) for products manufactured in Poland.

If the marketing authorisation holder is a foreign company and the medicinal product is manufactured in Poland, then the marketing authorisation holder must authorise the manufacturer to apply for a CPP.

If the marketing authorisation holder is a Polish company and the manufacturing of the medicinal product takes place outside Poland, then the marketing authorisation holder must apply for a CPP to a competent authority in the country where the product is manufactured.

A list of authorities that issue such certificates in each country is available on the WHO website.

When you should complete this procedure

Before the pharmaceutical product is placed on the foreign market.

Where you can complete this procedure

GŁÓWNY INSPEKTORAT FARMACEUTYCZNY ul. Senatorska 12, 00-082 Warszawa

What to do step by step

  1. Apply for the Certificate of Pharmaceutical Product

Before filing the application, call 22 44 10 705 or send an e-mail to: cpp@gif.gov.pl to obtain an individual number for the Certificate of Pharmaceutical Product.

Detailed instructions on how to complete the application can be found on the WHO website.

Documents

Time limit

Before the pharmaceutical product is placed on the foreign market.

  1. The authority will check your application

If your application contains formal deficiencies (e. g. you have made a mistake in the application, or you have not attached the necessary documents), the office will call you to correct the deficiencies. You will have at least 7 days from the date of receiving the request to make corrections. If you fail to correct errors within the deadline, your application will not be considered.

  1. You will receive the Certificate

Documents

You will receive a document as:
Oryginał

How much you will have to pay

Each issued Certificate is subject to a fee of PLN 17.

Additional fees may be required if the matter is handled by an attorney-in-fact (more on the power of attorney).

How long you will have to wait

You will receive the Certificate within 30 days from the date of submitting the application.

How can you appeal

If the office decides to refuse to issue the Certificate, you can request for your application to be reconsidered. Submit such request to the Chief Pharmaceutical Inspector (GIF) within 7 days from the date of delivery of the decision on refusal.

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